Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information

Recommended Actions

1. Review existing classification resources and databases before submitting a 513(g) request
2. Prepare a complete submission package including:
   • Signed cover letter with required information
   • Comprehensive device description
   • Detailed intended use information
   • Available labeling/promotional materials
3. Submit electronically via CDRH Portal (preferred) or other accepted methods
4. Pay required user fees before submission
5. Ensure submission addresses only one product
6. Be prepared to respond to FDA requests for additional information within 30 days
7. Consider contacting Office of Combination Products first if unclear about product jurisdiction
8. For specific testing recommendations, consider submitting a Q-submission instead of or after 513(g)

Key Considerations

Software

• Description of operational principles if device contains software/firmware should be included in the submission

Labelling

• Proposed labeling or promotional material must be included in the submission
• If available, include labeling/promotional material of similar legally marketed devices
• Prescription vs OTC use status should be specified

Other considerations

• Submission must include a signed cover letter identifying it as a “513(g) Request for Information”
• Complete device description including materials, components, photographs/drawings
• Description of device uses, including disease/condition, patient population, environment of use
• User fees must be paid before FDA will review the submission
• One submission should only seek information for a single product
• FDA will respond within 60 days of receipt
• Submissions can be made electronically via eCopy or eSTAR (preferred methods)

  Relevant Guidances

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• Content of Premarket Submissions for Device Software Functions
• Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
• Electronic Submission Template And Resource (eSTAR) for 510k Submissions

Related references and norms

• 21 CFR 860.3(i): Definition of “generic type of device”
• 21 CFR parts 862-892: Device classification regulations
• 21 CFR part 807, subpart E: Premarket Notification Procedures

---

Original guidance

• Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
• HTML / PDF
• Issue date: 2024-08-23
• Last changed date: 2024-08-22
• Status: FINAL
• Official FDA topics: Medical Devices, Premarket, Labeling, Biologics, Administrative / Procedural
• ReguVirta summary file ID: c24a25e3c573df7b9b6d343203399e29